Senior Vice President - Regulatory & Quality
Current
Nov 2023 - Present
AeroLeads people directory · profile
Bob Laughner Email & Phone Number
Regulatory and quality professional helping patients by delivering safe and effective medical innovations
at
Orchestra BioMed
1 work email found
@orchestrabiomed.com
2 phones found area 812
LinkedIn matched
✓ Verified Jul 2026
4 data sources
Profile completeness 100%
Current company
Role
Regulatory and quality professional helping patients by delivering safe and effective medical innovations
Location
Fort Lauderdale, Florida, United States
Who is Bob Laughner? Overview
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Quick answer
Bob Laughner is listed as Regulatory and quality professional helping patients by delivering safe and effective medical innovations at Orchestra BioMed, based in Fort Lauderdale, Florida, United States. AeroLeads shows a work email signal at orchestrabiomed.com, phone signal with area code 812, and a matched LinkedIn profile for Bob Laughner.
Bob Laughner previously worked as Senior Vice President - Regulatory & Quality at Orchestra Biomed and Vice President of Regulatory Affairs at Orchestra Biomed. Bob Laughner studied at Raps Regulatory Leadership Institute.
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{first_initial}{last}@orchestrabiomed.com
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Profile bio
About Bob Laughner
Demonstrated success in building effective partnerships across multiple business functions and geographies to deliver results. Experience in interfacing with regulatory agencies and negotiating with regulators. Expertise in development, testing, and regulation of drug-device and biologic-device combination products. Experience in developing regulatory strategies for domestic and international markets.Specialties: Regulation, Development, and Testing of Drug/Device and Biologic/Device Combination ProductsBiocompatibility of medical devices and combination productsClinical evaluation and critical analysis of scientific/medical literature.
Listed skills include Regulatory Affairs, Medical Devices, Regulatory Submissions, Fda, and 18 others.
Current workplace
Bob Laughner's current company
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8 roles
Bob Laughner work experience
A career timeline built from the work history available for this profile.
Vice President Of Regulatory Affairs
Apr 2020 - Nov 2023
Regulatory Director, Medical Device And Combination Products
Provide leadership to ensure effective and consistent device regulatory strategy across AstraZeneca's biologic combination product portfolio.Responsible for providing device and combination product regulatory expertise, guidance, and leadership to the development, testing, regulatory approval, and life-cycle management of biologic/device products. Lead the device-related strategy and execution for combination product regulatory submissions (e.g. INDs, CTAs, BLAs, MAAs, PMAs), and meetings with regulatory agencies. Effectively engage cross-functional teams locally and globally to drive consensus on complex development, quality, and regulatory concerns and to develop processes and guidance to support the development, approval, and life-cycle management of combination products.Evaluate new technologies and approaches for safe and effective combination products.Support the development and integration of connected delivery devices and app/software-basedcompanion platforms.Interface with regulators, industry, and organizations to develop and improve standards, guidance, and regulations related to combination products.
Jun 2018 - Apr 2020
Associate Director, Combination Products
Responsible for providing device and combination product expertise, guidance, input, and review to the development, testing, regulatory approval, and life-cycle management of biologic/device products. Support, contribute to, and review combination product regulatory submissions (e.g. INDs, CTAs, BLAs, MAAs, PMAs), and support meetings with regulatory agencies. Effectively engage cross-functional teams locally and globally to drive consensus on complex development, quality, and regulatory concerns and to develop processes and guidance to support the development, approval, and life-cycle management of combination products.Evaluate new technologies and approaches for safe and effective combination products.Interface with regulators, industry, and organizations to develop and improve standards, guidance, and regulations related to combination products.
Mar 2015 - May 2018
Regulatory Scientist
Effectively engage cross-functional teams at multiple levels to further regulatory, quality, and development goals. Responsible for providing regulatory and scientific (esp. pharmacological/toxicological) support and review for combination products (drug/device) and novel medical device technologies. Review and analyze scientific and medical data and literature in support of the product development process, testing development, and regulatory submissions. Serve as primary regulatory science support for the urology and ob/gyn product lines. Manage the clinical evidence report (CER) process, and drive the development and implementation of the company’s global CER process.
Aug 2008 - Feb 2015
International Regulatory Affairs Specialist
Responsible for interacting with distributors and regulatory authorities in Canada and Latin America to achieve and maintain medical device approvals. Responsible for providing regulatory and scientific (esp. pharmacological/toxicological) support and review for combination products (drug/device) and novel medical device technologies. Review and analyze scientific and medical data and literature in support of the product development process, testing development, and regulatory submissions. Manage the clinical evidence report (CER) process.
Aug 2007 - Aug 2008
Adjunct Professor
Develop curriculum and provide instruction related to regulatory affairs. Interface with university personnel and volunteers from multiple companies and organizations to ensure adequate staffing of class sessions.
Aug 2008 - May 2013
Associate Instructor
Instruction in undergraduate level Human Physiology - Leading laboratory sections, including both lecture and experimental components, and assisting with lecture and exam administration.
Aug 2005 - May 2007
4 education records
Bob Laughner education
Education record
Raps Regulatory Leadership Institute
Certificate, Introduction To Pharmaceutical Medicine
Karolinska Institutet
Ms, Pharmacology
Indiana University Bloomington
Ba, Biology
Indiana University Bloomington
FAQ
Frequently asked questions about Bob Laughner
Quick answers generated from the profile data available on this page.
What company does Bob Laughner work for?
Bob Laughner works for Orchestra BioMed.
What is Bob Laughner's role at Orchestra BioMed?
Bob Laughner is listed as Regulatory and quality professional helping patients by delivering safe and effective medical innovations at Orchestra BioMed.
What is Bob Laughner's email address?
AeroLeads has found 1 work email signal at @orchestrabiomed.com for Bob Laughner at Orchestra BioMed.
What is Bob Laughner's phone number?
AeroLeads has found 2 phone signal(s) with area code 812 for Bob Laughner at Orchestra BioMed.
Where is Bob Laughner based?
Bob Laughner is based in Fort Lauderdale, Florida, United States while working with Orchestra BioMed.
What companies has Bob Laughner worked for?
Bob Laughner has worked for Orchestra Biomed, Astrazeneca, Medimmune, Cook Medical, and Ivy Tech Community College.
How can I contact Bob Laughner?
You can use AeroLeads to view verified contact signals for Bob Laughner at Orchestra BioMed, including work email, phone, and LinkedIn data when available.
What schools did Bob Laughner attend?
Bob Laughner studied at Raps Regulatory Leadership Institute.
What skills is Bob Laughner known for?
Bob Laughner is listed with skills including Regulatory Affairs, Medical Devices, Regulatory Submissions, Fda, Iso 13485, Product Development, Pharmacology, and Biocompatibility.
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